Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2025-12-24 @ 2:46 PM
NCT ID:
NCT04586959
Eligibility Criteria:
Inclusion Criteria:
A subject will be considered eligible for inclusion in this study if all the following criteria are met:
1. Patient must be greater than or equal to 18 years old.
2. Suspected clinically early stage endometrial cancer of any histology (endometrioid, mixed, serous, clear-cell, carcinosarcomas, mucinous)
3. Pre-operative imaging not suggestive of extra-uterine disease, if obtained pre-operatively.
4. CA 125 testing is optional but, if obtained, must be within lab normal values. 5. ECOG performance status 0-2 (see appendix 1).
6\. Signed informed consent and ability to comply with follow-up. 7. Per the opinion of the treating investigator, the patient must be a suitable candidate for the MIS surgical procedure.
Exclusion Criteria:
A subject must not have any of the following criteria:
1. Planned laparotomic hysterectomy
2. On progesterone therapy to treat their endometrial cancer
3. Any prior pelvic irradiation
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT04586959
Study Brief:
Protocol Section:
NCT04586959